MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE SAFETY NEEDLE; PISTON SYRINGE

Model Number	305945
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd¿ syringe with permanently attached bd safetyglide¿ safety needle leaked during use.The following information was provided by the initial reporter: "leaking at the blue section.".
Event or Problem Description
It was reported that the bd¿ syringe with permanently attached bd safetyglide¿ safety needle leaked during use.The following information was provided by the initial reporter: "leaking at the blue section".
Additional Manufacturer Narrative
H6: investigation summary: since no samples (including photos) were returned for the reported issue of ¿leakage¿ with lot number unknown regarding item # 305945 the complaint could not be confirmed, and the root cause is undetermined.Unable to complete a dhr request as the lot number is unknown.Bd was not able to duplicate or confirm the indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no capa/sa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: BD SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE SAFETY NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12215616
• Report Number: 1920898-2021-00810
• Device Sequence Number: 4137052
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1